'Draft guidance' presentation slideshows

IOP Refinement

IOP Refinement. Trevor Warburton LOCSU Associate. Background. April 2009 New NICE Guidance. Optical comment to NICE.

681 views • 55 slides

Implementation of The Reduced Vertical Separation Minimum (RVSM) In Domestic U.S. Airspace

1.19k views • 51 slides

Update on Regulatory Requirements for Combination Products

I do not object to people looking at their watches when I'm speaking. But I strongly object when they start shaking them to make sure they are still going. William Norman Birkett. Update on Regulatory Requirements for Combination Products. Bradley Merrill Thompson, MBA, JD, RAC

608 views • 47 slides

Recent Trends in State Audits of Local G overnments Washington Association of County Officials Annual Conference Octobe

Recent Trends in State Audits of Local G overnments Washington Association of County Officials Annual Conference October 2, 2013. Organization chart. Troy Kelley State Auditor. Doug Cochran Chief of Staff. Vacant Director of Local Audit. Chuck Pfeil Director of Performance Audit. Jan Jutte

638 views • 46 slides

619 views • 45 slides

448 views • 36 slides

Vinod P. Shah, Ph.D. Chair, Topical Drug Products WG OPS/CDER/FDA

Dermatopharmacokinetics Perspectives from Bioequivalence Viewpoint Historical Development of Dermatopharmacokinetics and Overview of the Guidance. Vinod P. Shah, Ph.D. Chair, Topical Drug Products WG OPS/CDER/FDA. Historical Development of Dermatopharmacokinetics and Overview of the Guidance.

571 views • 33 slides

Update on Gene Therapy

Update on Gene Therapy. Dr. Nicola Stoner Specialist Principal Pharmacist Cancer Research UK & Oncology Unit Oxford Radcliffe Hospitals NHS Trust November 18th, 2003. Introduction. Gene therapy background Vectors Gene therapy strategies Patient monitoring Regulatory bodies

560 views • 30 slides

EER Assurance December 2018

EER Assurance December 2018. Agenda Item 8. December 12, 2018. Recap of September Meeting. Key areas for further consideration: Guidance covering matters not explicitly addressed in ISAE 3000 (Revised) requirements Consistency with ISAE 3000 (Revised) requirements Suitability of criteria

342 views • 25 slides

Discussion: Biostatistics in Public Policy

Discussion: Biostatistics in Public Policy. Greg Campbell, Ph.D. Director, Division of Biostatistics Center for Devices and Radiological Health Food and Drug Administration Statistics in Public Policy, ASA, February 3, 2012. Outline. Biostatisticians FDA Advisory Committees

311 views • 19 slides

The Allied Health Professions and Education Partnership Working Project

The Allied Health Professions and Education Partnership Working Project CYPHSG December 7 th 2009. Nicola Robinson AHP Development Officer nicola.robinson@scotland.gsi.gov.uk Douglas Hutchison HMIE, Development Officer douglas.hutchison@scotland.gsi.gov.uk.

310 views • 18 slides

Updates from Office of Air Monitoring and Analysis

Updates from Office of Air Monitoring and Analysis. Alice H. Chow Associate Director. Requests for updates. Proposed Ozone Monitoring changes PAMS Re-engineering Emissions Inventory Draft for SIP development. Proposed Ozone Monitoring Changes.

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301 views • 17 slides

Office of Generic Drugs Research Program

Office of Generic Drugs Research Program. Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER, FDA ACPS Meeting, Oct. 22, 2003. Definition of a Generic Drug. Approved Generic Products are Therapeutically Equivalent to a Reference Listed Drug

298 views • 16 slides

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Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD

Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD. Introductory Remarks. Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research. Accomplishments of Committee in the Last Three Years.

216 views • 14 slides

Comparability Protocols

Comparability Protocols . Nancy Sager Associate Director, QIS-Chemistry FDA/CDER/OPS. What is a comparability protocol? Why has FDA issued a guidance on comparability protocols? What are the benefits of using comparability protocols? Why are we making the ACPS aware of this guidance?

1.45k views • 12 slides

CERP Guidance Memorandum

CERP Guidance Memorandum. Recreation and Public Use Planning. CERP Goals and Objectives. Goal: Enhance Ecological Values Increase the total spatial extent of natural areas Improve habitat and functional quality Improve native plant and animal species abundance and diversity

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Exceptional Events and Region 9 AMTAC April 12 , 2011

Exceptional Events and Region 9 AMTAC April 12 , 2011. The Exceptional Events Rule & R9:. The Exceptional Events Rule (EER) is the only mechanism that allows S/L/Ts to exclude data* from regulatory decisions. R9 has > 45,000 exceptional event flags in AQS.

146 views • 6 slides